Medline procedural kits may contain non-sterile ultrasound gel
Medline is recalling 4,900 sterile procedural kits used for arterial line insertion because the ultrasound gel component may not meet sterility specifications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall involving a potential sterility failure in a critical sterile component. While the hazard presents a significant risk of contamination and infection in vulnerable patients undergoing invasive procedures, no illnesses or injuries have been reported, placing it in the High category per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling Custom Sterile and Non-Sterile Procedural Kits distributed between April 1, 2020 and April 28, 2023. The recalled kits include multiple models used for arterial line insertion procedures, including the ART LINE KIT ICH OR (Model ART900), ART LINE SECUREMENT KIT W/LIDOCAINE (Model DT22570), ARTERIAL BUNDLE NO CATHETER (Model ART995), and six additional models.
The recall was initiated because the Turkuaz Ultrasound Gel component within these kits has the potential to not meet sterility specifications. Ultrasound gel is a critical sterile component in these procedural kits, and failure to maintain sterility could introduce bacterial or other microbial contamination during medical procedures.
The affected kits have been distributed worldwide, including throughout the United States and to Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, and the United Arab Emirates. Approximately 4,900 kits are affected by this recall.
Patients and healthcare providers should discontinue use of the recalled kits and contact Medline Industries for instructions on replacement or return. No illnesses or injuries associated with this issue have been reported to date.
The recalled product
- Product
- Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ART LINE KIT ICH OR, Model Number: ART900; b. ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number: DT22570; c. ARTERIAL BUNDLE NO CATHETER, Model Number: ART
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- sterility-failure
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- UPC Number: 10653160342540. b. Model Number: DT22570
- UPC Number: 10653160343851. c. Model Number: ART995
- UPC Number: 10193489190502. d. Model Number: ART775B
- UPC Number: 10653160353560. e. Model Number: ART890A
- UPC Number: 10653160356677. f. Model Number: ART1160
- UPC Number: 10653160355762. g. Model Number: P42453
- UPC Number: 10653160323792. h. Model Number: ART1180
Distribution
Distributed nationwide across the United States.
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